Needle guide including enhanced visibility entrance

ABSTRACT

Needle guide systems for a sonography device are disclosed. The needle guide systems include both fixed and adjustable needle guides. In one embodiment, the needle guide includes a needle guide body that is rotatably mounted to a probe of a sonography device. A plurality of needle channels is disposed on a surface of the needle guide body. Each needle channel can be selectively rotated into position to guide a needle into a body of a patient at a predetermined needle insertion angle. If another needle insertion angle is desired, the needle guide is rotated to place a new needle channel defining the desired needle insertion angle into position. In another embodiment, a needle guide is disclosed and includes an extended guide feature, such as a guide cone, to assist in inserting a needle into the needle channel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Design patentapplication Ser. No. 29/493,150, filed Jun. 5, 2014, now U.S. Pat. No.D752,743, which is a continuation of U.S. patent application Ser. No.13/886,196, filed May 2, 2013, now U.S. Pat. No. 10,231,697, which is adivision of U.S. patent application Ser. No. 12/642,456, filed Dec. 18,2009, now U.S. Pat. No. 8,574,160, which claims the benefit of U.S.Provisional Patent Application No. 61/138,606, filed Dec. 18, 2008. Thisapplication also claims the benefit of U.S. Provisional PatentApplication No. 61/920,242, filed Dec. 23, 2013. Each of theaforementioned applications is incorporated herein by reference in itsentirety.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toneedle guide systems for a sonography device. The needle guide systemsinclude both fixed and adjustable needle guides for use with a probe ofthe sonography device.

In one embodiment, the needle guide includes a needle guide body that isrotatably mounted to a sonography device probe. A plurality of needlechannels is disposed on a surface of the needle guide body. Each needlechannel can be selectively rotated into position to guide a needle intoa body of a patient at a predetermined needle insertion angle. Ifanother needle insertion angle is desired, the needle guide is rotatedto place a new needle channel defining the desired needle insertionangle into position. The needle guide can be permanently or removablyattached to the probe.

In another embodiment, a needle guide is disclosed and includes anextended guide feature, such as a guide cone, to assist in inserting aneedle into the needle channel.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is simplified perspective view of a sonographic imaging systemthat serves as an example environment in which embodiments of thepresent invention can be practiced;

FIG. 2 is a perspective view of a handheld probe of the system of FIG.1;

FIGS. 3A and 3B are various views of a portion of a needle guide systemincluded on a handheld probe according to one example embodiment,included on the probe of FIG. 2;

FIGS. 4A-4D are various views of a needle guide for use with thehandheld probe shown in FIGS. 3A and 3B, according to one embodiment;

FIG. 4E is a perspective view of the needle guide of FIGS. 4A-4Dattached to the probe of FIG. 2;

FIGS. 5A-6E are various views of an adjustable needle guide systemaccording to one embodiment;

FIGS. 7A-8F are various views of an adjustable needle guide systemaccording to another embodiment;

FIGS. 9A-10F are various views of an adjustable needle guide systemaccording to yet another embodiment;

FIGS. 11A-11D show additional details of a needle guide system accordingto one embodiment;

FIG. 12 is a top view of an adjustable needle guide system according toone another embodiment;

FIG. 13 is a top view of an adjustable needle guide system according toyet another embodiment;

FIGS. 14A-14C show various views of a connector included on anultrasound probe;

FIGS. 15A-15F show various views of a needle guide according to oneembodiment;

FIG. 16 is a perspective view of an ultrasound probe with the needleguide of FIGS. 15A-15F attached to a connector of the probe;

FIGS. 17A-17G are various views of needle guides according to certainembodiments;

FIG. 18 is an end view of a needle guide according to one embodiment;

FIGS. 19A and 19B are various views of a needle guide according to oneembodiment;

FIGS. 20A and 20B are various views of a needle guide according to oneembodiment;

FIG. 21 is a top view of a needle guide according to one embodiment;

FIG. 22 is a top view of a needle guide according to one embodiment; and

FIG. 23 is a top view of a needle guide according to one embodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of a needleor catheter placed within the body of a patient is considered a distalend of the needle or catheter, while the needle or catheter endremaining outside the body is a proximal end of the needle or catheter.Also, the words “including,” “has,” and “having,” as used herein,including the claims, shall have the same meaning as the word“comprising.”

FIGS. 1-11D depict various features of embodiments of the presentinvention, which are generally directed to needle guide systems for usewith a sonographic imaging device in assisting the percutaneousinsertion of a needle or other medical device into a body portion, suchas a vasculature of a patient, for instance.

Reference is first made to FIG. 1 in describing a sonographic imagingsystem (“system”), generally described at 10, for ultrasonically imagingportions of a patient body. The system 10 includes a console 12including a display 14 and one or more user input controls 16. In oneembodiment, the system 10 also includes a probe 18 including one or moreuser controls in the form of control buttons 20. Briefly, the probe 18is configured to transmit ultrasonic signals from a head portion 18Athereof into a portion of a patient body and to receive the ultrasonicsignals after reflection by internal structures of the patient body. Thesystem 10 processes the reflected ultrasonic signals for depiction onthe display 14.

The user input controls 16 of the console 12 may include, for example,image gain controls to adjust the amplification of a received ultrasonicsignal, image depth controls to image structures at different depths andadjust the focus of an ultrasonic image displayed on the display 14,depth marker controls to selectively display depth markers and/or gridlines, print and/or save controls to print/save an image currentlydisplayed on the display, image freeze controls to pause an imagecurrently displayed on the display, time/date set controls, and othercontrols for operating the system 10. Corresponding controls, or asubset thereof, are also included in the control buttons 20 on the probe18. In addition, in other embodiments the functionality of the userinput controls 16 can be provided by a keyboard, mouse, or othersuitable input device.

FIG. 2 shows the probe 18 of FIG. 1, including two needle guideconnectors 30 that are included as part of a needle guide mountingsystem configured in accordance with one example embodiment. The needleguide connectors 30 are included on front and side portions of the probe18 but are identically configured in the present embodiment. As such,the details of only one of the connectors will be described in detailhere. It should be appreciated that in other embodiments the needleguide connectors may differ in size, configuration, the number includedon the probe, etc. In addition, the design and configuration of theprobe is merely one example of an ultrasonic probe that can benefit fromthe principles described herein.

FIGS. 3A and 3B give further details of the needle guide connectors 30according to one embodiment. Each connector 30 includes an elongatefirst mounting surface 32, extending from the surface of the probe headportion 18A, which is configured to receive a needle guide thereon, aswill be described. An overhang 34 is defined at an end of the mountingsurface 32 for assistance in maintaining engagement of the needle guidewith the connector 30. A second mounting surface 36 is also included onthe each connector 30, which surface defines two stability extensions36A, 36B. In the present embodiment, the stability extensions 36A, 36Bare integrally formed with the first mounting surface 32 and extendalong an axis in a direction that is substantially orthogonal to alongitudinal axis of the first mounting surface. So configured, thesecond mounting surface 36, as defined by the stability extensions 36Aand 36B, also extends substantially orthogonal to the first mountingsurface 32, though in other embodiments the two mounting surfaces can bealigned at other angles with respect to one another. Note that the size,number, and orientation of the second mounting surface and itsrespective stability extensions with respect to the first mountingsurface can vary from what is explicitly described herein.

One or more depressions 40 are defined on side surfaces of the firstmounting surface 32 for engagement with corresponding protrusionsdefined on the needle guide, as will be described. Of course, otherconfigurations for maintaining engagement between the needle guide andthe mounting surfaces of the needle guide connector 30 can also beemployed.

Reference is now made to FIGS. 4A-4D, which depict various details of aneedle guide, generally designated at 50, in accordance with one exampleembodiment. As shown, the needle guide 50 includes a top surface 52 onwhich a needle channel 54, defined by two lips 55, is defined forguiding a needle to a body portion imaged by the system 10 viapercutaneous insertion. The top surface 52, and therefore the needlechannel 54, is angled with respect to a longitudinal axis of the probe18 so as to enable the needle to intercept the targeted body portion ata depth as determined by the ultrasonic imaging performed by the system10. The needle insertion angle defined by the needle channel 54 can varyaccording to the configuration of the needle guide. Thus, selection ofan appropriately angled needle guide is determined by the depth of theintended subcutaneous target within the patient body to be intercepted.As such, the specific size and configuration details of the needle guidedescribed herein are merely examples.

The needle guide 50 defines a first cavity 56, best seen in FIG. 4D,which is shaped to receive therein the first mounting surface 32 of theconnector 30 when the needle guide is removably attached to the probe18. A smoothly shaped extended surface 58 is included at the closed endof the cavity 56 and is configured for interfacing with the smoothlyshaped overhang 34 of the first mounting surface 32 in retaining theneedle guide 50 on the connector 30 when attached thereto. The extendedsurface 58 and overhang 34 can be configured in a variety of ways so asto assist in retaining the needle guide on the connector 30.

A second cavity 60, which crosses substantially orthogonally the firstcavity 56 and includes notches 60A, 60B, is defined by the body of theneedle guide 50, as best seen in FIG. 4B. The notches 60A, 60B of thesecond cavity 60 are positioned to respectively receive therein thestability extensions 36A, 36B when the needle guide 50 is attached tothe needle guide connector 30, such as in a snap-fit configuration forinstance, as shown in FIG. 4E. So attached, the stability extensions36A, 36B of the connector 30 engage the notches 60A, 60B and thisengagement, together with the engagement of the first mounting surface32 with the needle guide cavity 56, secures the needle guide in placewith respect to the probe 18. This in turn provides a stable needleguide structure that resists undesired movement, such as the needleguide undesirably slipping off the probe in a direction parallel to alongitudinal axis of the probe 18. Thus, the needle guide remains inplace to enable a clinician to insert a needle or other medicalinstrument into the target area of the patient body via the needlechannel 54 while the target area is imaged by the sonography system 10.It is appreciated that the angle of intersection between the firstcavity 56 and the second cavity 60 of the needle guide 50 should beconfigured to match the angle of intersection between the first mountingsurface 32 and the second mounting surface 36 of the needle guideconnector 30 of the probe 18 in all cases, regardless of whether theangle of intersection is orthogonal.

The needle guide 50 further includes protrusions 70 in the first cavity56 that are sized and positioned to engage with the depressions 40(FIGS. 3A, 3B) of the needle guide connector 30 when the needle guide isattached to the needle guide connector 30. Note that the size, shape,number, and other configuration details of the needle guide cavities canvary from what is described herein while still residing within the scopeof present embodiments. For instance, the shape defined by the notches60A, 60B, can be triangular, rounded, etc., instead of the squareconfiguration shown here.

The needle channel 54 of FIGS. 4A-4E is shown to be sized for an 18Gauge needle. In other embodiments, however, the needle channel can besized to accommodate needles of other sizes and configurations. Also,the needle guide can be configured in one embodiment to accept devicesother than needles, such as trocars or catheters for instance. Asmentioned above, the needle guide top surface can be configured suchthat the needle channel defines an angle with a longitudinal axis of theprobe 18 different from what is shown in FIGS. 4A-4E. As such, multipleneedle guides, each having a needle channel defining a unique angle withthe longitudinal axis of the probe 18, can be constructed as to beselectively attachable to/removable from the probe needle guideconnector 30 of the probe 18, enabling a plurality of needle insertionangles to be achieved with the system 10.

Reference is now made to FIGS. 5A-6E in describing a needle guide systemaccording to another embodiment. FIGS. 5A and 5B show the probe 18including a mounting component, such as a mounting ball 360, on theprobe head portion 18A for rotatably receiving a rotatable needle guide350, shown in FIGS. 6A and 6B. As shown, the needle guide 350 includes acircular body that defines a chamfered or slanted top surface 352. Aplurality of needle channels 354 is included on the top surface. Eachneedle channel 354 is defined by two lips 455 or other suitablestructure. The top surface 352 is configured such that each needlechannel 354 is positioned at a unique angle. For instance, FIG. 6B showsone needle channel 354 of the needle guide 350 angled to define adeflection angle φ₁ with respect to horizontal and another needlechannel 354 angled to define a deflection angle φ₂ with respect tohorizontal, from the perspective shown in FIG. 6B. As will be seen, thisenables the needle guide to guide a needle into the patient body at oneof a plurality of different needle insertion angles, measured withrespect to a longitudinal axis of the probe 18 to which the needle guideis either removably or permanently attached. In the illustratedembodiment, five needle channels 354 are included on the top surface 352of the needle guide 350, though more or fewer than this can be included.Also, though shown distributed in a star pattern, the distribution ofthe needle channels on the needle guide top surface can vary from whatis shown and described herein.

As mentioned, the needle guide 350 is configured to attach to a fixtureon the probe 18, such as the mounting ball 360 shown in FIGS. 5A and 5Bor other suitable structure, such that the needle guide 350 is rotatablewith respect to the probe. The fixture can be placed on any suitablesurface of the probe 18. One or more protrusions 362 are included on abottom surface of the needle guide 350 and are each positioned so as toengage a depression 364 defined on the surface of the probe head portion18A and thus secure the needle guide in a particular position untilmoved by a force sufficient to overcome the friction engagement betweenthe corresponding protrusion and the depression. So configured, aclinician may rotate the needle guide 350, as shown in FIG. 6C, untilthe desired needle channel 354 having the desired insertion angle isaligned at a usable position 354A to enable the clinician to insert acorrespondingly sized needle into the patient body via the selectedneedle channel to intercept an imaged target area of the patient body ata predetermined depth. Note that the location, number, and configurationof the protrusions and depressions can vary from what is shown anddescribed.

FIGS. 6D and 6E show how the needle guide 350 enables needle insertionsof different angles of entry into the patient body. In FIG. 6D, one ofthe needle channels 354 is positioned for use, i.e., in the position354A (see FIG. 6C) such that it defines a needle insertion angle θ₁ withthe longitudinal axis 380 of the probe 18. In contrast, FIG. 6E showsanother needle guide channel 354 in the position 354A, which defines aneedle insertion angle θ₂ with the probe longitudinal axis 380. As canbe seen from FIGS. 6D and 6E, the needle path enabled by the needlechannel 354 of FIG. 6D penetrates more deeply relative to the needlepath enabled by the needle channel 354 of FIG. 6E. As such, the needlechannel 354 of FIG. 6D can be employed in order to enable a needle tointercept a target area of the patient body that is relatively deeper,while the needle channel shown in FIG. 6E can be employed to intercept arelatively shallower target area.

Thus, in accordance with the present embodiment, the needle guide 350can be used to direct a needle to a proper depth within the patient bodyduring use of the probe 18 and system 10. In particular, once a targetarea of the patient body has been located by the probe 18 and imaged bythe system 10, the clinician rotates the needle guide 350 until adesired one of the needle channels 354 having a desired needle insertionangle with respect to the longitudinal axis 380 of the probe 18 is inthe position 354A and ready for use. The clinician can then insert theneedle into the needle channel 354, which channel guides the needle intothe patient body at the desired needle insertion angle until the needleintercepts the target area.

Note that the shape and size of the needle guide can vary from what isdescribed here. For instance, the general shape of the needle guide canbe hexagonal, pentagonal, triangular, square, or other geometric shapein one embodiment. Also, the needle guide can be reduced in size fromwhat is shown in FIGS. 6D and 6E in order to match a configuration ofthe sonographic probe. The needle channels can each be sized toaccommodate needles of differing gauges in one embodiment.

Reference is now made to FIGS. 7A-8E in describing a needle guide systemaccording to another embodiment. In particular, FIGS. 8A-8E show aneedle guide 450, which generally includes a base 452 and a flexibleextension 460. The base 452 includes on a top surface thereof a needlechannel 454 defined by lips 455 and on a bottom surface a connector 456for attaching the needle guide 450 to the probe 18 and longitudinallyextending stability rails 458 for preventing twisting or torsion of theneedle guide during use on the probe. The flexible extension 460 is anelongate member that longitudinally extends from the base 452 andincludes a first engagement feature, such as a hook 462, at a free end460A of the extension.

As shown in FIGS. 7A and 7B, in the present embodiment the probe 18includes on its head portion 18A a connector 470 to which the needleguide can removably attach. The connector 470, which itself can beremovably or permanently attached to the probe 18, includes a cavity 472for receiving the connector 456 of the needle guide base 452, and asupport arm 474 proximally extending at an acute angle from the probesurface. The probe 18 further includes a receiver array 480, whichincludes a second engagement feature, configured here as a plurality ofspaced apart bars 482 with which the needle guide hook 462 can engage,as shown in FIG. 8F, for example. Specifically, FIG. 8F shows the needleguide 450 attached to the probe 18 via engagement of its connector 456with the cavity 472 of the probe connector 470. The hook 462 of theneedle guide flexible extension 460 is shown engaged with one of thehook receiving bars 482 of the receiver array 480, thus creating anattachment between the first engagement feature of the needle guide,i.e., the hook 462, and the second engagement feature of the probe,i.e., one of the bars 482.

So configured, the needle channel 454 of the needle guide is oriented todefine a needle insertion angle θ with the probe longitudinal axis 380.Note that the extension 460 is configured to be flexible enough to allowfor the bending thereof as shown in FIG. 8F. The support arm 474 in thecurrent embodiment is resilient while also providing the needed rigidityfor the needle guide base 452 so as to maintain the needle channel 454in a substantially fixed location after the angle of the needle guide450 has been selected and set. Additionally, the stability rails 458straddle the support arm 474 to prevent undesired twisting or torsion ofthe needle guide 450 during use.

Should it be desired to change the needle insertion angle defined by theneedle channel 454, the hook 462 can be manually moved to engage anotherof the bars 482 of the probe receiver array 480. This in turn alters theneedle insertion angle and the depth to which the needle will beinserted into the patient body by the clinician. Generally, in thepresent embodiment movement of the hook 462 to more proximal bars 482lessens the needle insertion angle, which in turn enables the needle topenetrate to a relatively deeper target area in the patient body. Ofcourse, the needle guide system can be configured such that a differentrelationship exists between movement of the needle guide components andthe needle insertion angle. Indeed, in one embodiment the adjustableengagement feature can be included on the needle guide itself instead ofon the probe, as is the case with the embodiment described here.

FIGS. 9A-9E depict a variation of the needle guide 450, wherein the freeend 460A of the flexible extension 460 serves as a first engagementfeature of the needle guide in contrast to the hook of the previousembodiment, and wherein a receiver array 580 on the probe 18 (FIG. 10A)includes a second engagement feature implemented as a plurality of slots582 instead of the bars of the previous embodiment. Further, the needleguide 450 shown in FIGS. 9A-9E is designed for use with a probeconnector that includes no support arm, such as the support arm 474shown in FIGS. 7A-8F. Instead, the flexible extension 460 in the presentembodiment is configured so as to be more rigid, relative to theflexible extension of the embodiment depicted in FIGS. 7A-8F, thusenabling it to bend to engage the receiver array 580 while maintainingthe needle guide base 452 at a desired position.

In greater detail, FIGS. 10A-10F show the manner of engagement of theneedle guide 450 with the probe 18, according to the first and secondengagement features just described above in connection with FIGS. 9A-9E.Note that in FIGS. 10A-10F, the probe connector for attachment of theneedle guide has been removed for clarity. In particular, FIG. 10A showsthe flexible extension 460 positioned such that the free end 460Athereof is received into the distal-most slot 582 of the probe receiverarray 580. This causes the needle guide base 452 and the needle channel454 disposed thereon to be positioned such that the needle channeldefines a relatively large needle insertion angle θ with respect to theprobe longitudinal axis 380, which corresponds to inserting a needle ina relatively superficial target area of the patient body locatedproximate the skin surface thereof.

FIGS. 10B-10F show that as the flexible extension free end 460A of theneedle guide 450 is inserted into progressively more proximal slots 582of the probe receiver array 580, the needle insertion angle θ isreduced, which corresponds to directing the needle to progressivelydeeper target areas of the patient body. As such, the slots 582 andneedle guide 450 can be configured so as to position the needle channel454 to define predetermined needle insertion angles. In one embodiment,for example, the needle guide system as described in connection withFIGS. 9A-10F can define needle insertion angles ranging from about threedegrees to about 43 degrees, though it is appreciated that a variety ofpossible angles can be achieved. It is noted that the first and secondengagement features of the needle guide and probe that are used tointerconnect the two can vary from what is described herein, asappreciated by one skilled in the art.

FIGS. 11A-11D depict one possible connector 670 for the probe headportion 18A for engaging a needle guide, according to one embodiment. Inparticular, the connector 670 includes two outer fins 672 in betweenwhich an inner fin 674 is positioned. As best seen in FIG. 11D, a recess676 is included on the inner fin 674, and the outer fins 672, the innerfin 674, or all the fins include a resilient material so as to enabledeformation thereof so as to facilitate insertion into the recess of aconnector portion of the needle guide, such as the connector 456 of theneedle guide 450 described in the embodiment associated with FIGS.7A-8F, for example. In one embodiment, only the inner fin is resilient,while the outer fins are substantially rigid. It should therefore beappreciated that the manner of attachment between the needle guide andthe probe can include any one of a number of possible designs. Also, itis appreciated that the needle channel can be defined in any one of anumber of ways, in addition to the lips explicitly shown and describedherein.

FIGS. 12 and 13 depict yet other needle guide embodiments. In FIG. 12, alinear needle guide 750 is shown, including a top surface 752 on whichare disposed a plurality of needle channels 354 that are each aligned todefine differing needle insertion angles. A particular needle channelcan be selected for use by laterally sliding the needle guide 750 asshown in FIG. 12. In FIG. 13, a semi-circular needle guide 850 is shown,including a top surface 852 on which a plurality of needle channels 354are disposed in a fan pattern, each needle channel defining a differentneedle insertion angle. Finger grips 855 can be included on the body ofthe needle guide 850 to assist with movement of thereof to position adesired needle channel for use. These embodiments are thereforeillustrative of the many different needle guide configurations possible.

FIGS. 14A-16 depict various details of a needle guide/connector systemfor use with a probe, such as an ultrasound probe, according to oneembodiment. In particular, FIGS. 14A-14C depict various details of theconnector 30 included on the head portion 18A of the probe 18, accordingto the present embodiment. As the embodiment of FIGS. 14A-14C sharessome similarity with the connector shown in FIGS. 3A and 3B, onlyselected aspects of the present connector 30 will be discussed.

As shown in FIGS. 14A-14C, the connector 30 includes the first mountingsurface 32 that terminates in the overhang 34. The second mountingsurface 36 is also depicted, including the extensions 36A and 36B, forproviding stability to a needle guide attached to the connector 30, aswill be discussed further below. In contrast to the embodiment of theconnector of FIGS. 3A and 3B, the extensions 36A and 36B here define arounded shape. As mentioned, other extension shapes are possible. Thedepressions 40 are provided on either side of the connector 30, asbefore. The particular position of the connector 30, and its particulardesign, can vary from what is shown and described herein.

FIGS. 15A-15F depict various details of the needle guide 50 for use withthe connector 30 of FIGS. 14A-14C, according to one embodiment. As thepresent embodiment shares some similarity with the needle guide shown inFIGS. 3A and 3B, only selected aspects of the present needle guide 50will be discussed.

Note that the needle guides to be described in the following embodimentsherein are configured so as to ease insertion of the needle into a guidechannel of the needle guide. This facilitates ease of needle insertioneven when the needle guide is positioned relatively far away from theuser, such as is the case when the needle guide is included with a probeof an ultrasound imaging system and it is necessary to maintain theprobe on the skin surface of the patient during loading of the needleinto the needle guide. This circumstance arises, for instance, when theultrasound imaging system includes a magnetic-based needle insertionguidance system, which often requires the ultrasound probe and attachedneedle guide to remain on the skin of the patient after magneticcalibration of the guidance system. Further details regarding an exampleof a magnetic-based needle insertion guidance system can be found inU.S. Pat. No. 10,524,691, filed Sep. 27, 2013, and titled “NeedleAssembly Including an Aligned Magnetic Element,” which is incorporatedherein by reference in its entirety.

In light of the above, FIGS. 15A-15F depict various details of theneedle guide 50, configured for removable attachment to the connector 30of FIGS. 14A-14C or other portion of the ultrasound probe 18, inaccordance with the present embodiment. As shown, the needle guide 50includes the top surface 52 supported by one or more legs 53. The topsurface 52 serves as the platform on which the needle channel 54—definedby two opposing, elongate lips 55 with a slot 55A interposedtherebetween—is included for guiding a needle to a body portion imagedby the ultrasound imaging system 10 via percutaneous insertion. When theneedle guide 50 is attached to the probe, the top surface 52, andtherefore the needle channel 54, is angled with respect to alongitudinal axis of the probe 18 so as to enable the needle tointercept the targeted body portion at a depth as determined by theultrasonic imaging performed by the system 10. The needle insertionangle defined by the needle channel 54 can vary according to theconfiguration of the needle guide.

The needle guide 50 defines the cavity 56, best seen in FIGS. 15C and15F, which is shaped to receive therein a connector, such as theconnector 30 of the ultrasound probe 18 in FIGS. 14A-14C, or otherapparatus to which the needle guide is to attach. The smoothly shapedextended surface 58 is included at the closed end of the cavity 56 andis configured for interfacing with the overhang portion 34 of theconnector 30 of the probe when attached thereto. The extended surface 58is but one example of a feature included on the needle guide 50 toassist in retaining the needle guide on the connector 30. Note that theneedle guide 50 in the present embodiment is removably attachable to aconnector disposed on the ultrasound probe, such as in a snap-fitarrangement; in other embodiments, permanent attachment of the needleguide to a probe or other device is possible. In yet another embodiment,the needle guide attaches to a cap or other component that in turnattaches to the probe.

Notches 61 are defined in the legs 53 of the needle guide body, as bestseen in FIGS. 15B and 15F and are positioned to respectively receivetherein the extensions 36A, 36B of the connector 30 included on theprobe 18 (FIGS. 14A-14C). This serves to enhance the stability of theconnection between the needle guide 50 and the connector 30 in order toresist undesired needle guide movement while the attached to the probe18. As mentioned, note that the size, shape, number, and configurationof the notches can vary from what is shown and described herein.

The needle guide 50 further includes two protrusions 70 in the cavity 56that are sized and positioned to engage with the corresponding twodepressions 40 of the needle guide connector 30 on the probe 18 (FIGS.14A-14C). Note that the size, shape, number, and other configurationdetails of the needle guide protrusions and cavity itself can vary fromwhat is described herein while still residing within the scope ofpresent embodiments.

The needle channel 54 of FIGS. 15A-15F is shown to be sized for a 21Gauge needle. In other embodiments, however, the needle channel can besized to accommodate needles of other sizes and configurations. Also,the needle guide can be configured in one embodiment to accept devicesother than needles, such as trocars or catheters for instance.

As mentioned above, the needle guide top surface 52 is oriented suchthat the needle channel 54 defines an angle with a longitudinal axis ofthe probe. For instance, the top surface 52 and needle channel 54 of theneedle guide 50 shown in FIGS. 15A-15F are angled so as to intercept anextension of the longitudinal axis of the probe 18 at a distance ofabout two centimeters below the probe head portion 18A. As will be seen,other angles can be defined by the top surface/needle channel. Also, inother embodiments the needle channel can be included on other than thetop surface of the needle guide body, such as a side surface, forinstance.

The needle guide 50 further includes an extended guide feature forfacilitating the ease of insertion of a needle into a proximal end ofthe needle channel 54. “Extended guide feature” as used herein includesfeatures, components, elements, etc. that enhance the ability for aneedle to be guided by a user toward/into the needle channel of theneedle guide. In the present embodiment, the extended guide featureincludes a guide cone 80, disposed at the proximal end 50A of the needleguide 50, which extends from the top surface 52 of the needle guide 50and is defined by proximal portions of the lips 55 so as to be incommunication with the needle channel 54.

As shown, the guide cone 80 is elliptically funnel-shaped so as toprovide a tapered, elliptically conical three-dimensional funnel surface84 that guides a distal tip of a needle toward the needle channel 54. Assuch, the guide cone 80 provides a relatively large target easilyviewable and accessible by a clinician using the needle guide. This inturn obviates the need for the clinician to remove the probe 18 (FIGS.14A-14C) from the skin of the patient during ultrasound imagingprocedures in order to insert the needle into an otherwise relativelysmall needle channel of the needle guide attached to the probe. As hasbeen discussed above, such removal of the probe 18 from the skin of thepatient is undesired and can undermine the effectiveness ofmagnetic-based needle insertion guidance systems associated with theultrasound imaging system, which guidance systems often require theprobe not to be moved from the patient's skin after magnetic calibrationhas been performed.

In greater detail, FIG. 15C shows that the guide cone 80 includes anelliptical perimeter 82 that in turn includes a leading edge 82A and atrailing edge 82B. The leading edge 82A includes approximately half theperimeter 82, i.e., the portion of the perimeter disposed above the topsurface 52 of the needle guide 50 from the perspective of FIG. 15C.Thus, the leading edge 82A of the perimeter 82 bounds the portion of theguide cone that is disposed above the needle guide top surface 52, whichis also referred to herein as being above in an orthogonal directionwith respect to the top surface. The trailing edge 82B of the perimeter82 bounds the portion of the guide cone 80 that is disposed below thetop surface 52 of the needle guide 50, also referred to herein as beingbelow in an orthogonal direction with respect to the top surface.

FIG. 15B shows that a forward extending portion 86 of the guide cone 80extends beyond the proximal end 50A of the needle guide 50. Further, theleading edge 82A of the perimeter 82 extends proximally further awayfrom the body of the needle guide 50 relative to the trailing edge 82B,with the perimeter being included on the forward extending portion 86.Note, however, that the shape and configuration of the guide cone, itsperimeter, and the leading and trailing edges can vary from what isshown and described herein. For instance, the guide cone can define around funnel shape. In another embodiment, the perimeter of the guidecone can be coincident with the proximal end of the needle guide insteadof extending past the proximal end. Note that the needle guide in oneembodiment is formed from a suitable thermoplastic, such as low-densitypolyethylene, though other materials could also be employed. Desiredcharacteristics for the needle guide material in one embodiment includethe ability of the material to form a needle channel that is firm enoughto retain the needle therein, yet flexible sufficient to enable the lipsof the needle channel to deform and release the needle from the needlechannel.

FIG. 16 depicts the manner of attachment of the needle guide 50 of FIGS.15A-15F with the connector 30 of FIGS. 14A-14C. As shown, the connector30 is received within the cavity 56 of the needle guide 50 such that theextended surface 58 in the cavity snap-fits over the overhang 34 of theconnector. Additionally, the protrusions 70 disposed in the needle guidecavity 56 are received in the corresponding depressions 40 to furtherthe snap-fit attachment of the needle guide 50 to the connector 30.

In this attached state, FIG. 16 further shows that the notches 61 of theneedle guide 50 are positioned to receive therein the correspondingextensions 36A, 36B when the needle guide is attached to the connector30. So attached, and as with previous embodiments, the stabilityextensions 36A, 36B of the connector 30 engage the notches 61 to helpsecure the needle guide in place with respect to the probe 18. Shoulddetachment of the needle guide 50 from the connector 30 be desired, theuser can simply pull the needle guide from the connector to overcome thesnap-fit arrangement.

Reference is now made to FIGS. 17A-17G. As mentioned above in connectionwith FIGS. 15A-15F, the needle guide top surface 52 can be oriented suchthat the needle channel 54 defines an angle with a longitudinal axis ofthe probe (FIGS. 14A-14C, 16) different from what is shown in FIGS.15A-15F. In one embodiment, this is achieved by altering the length ofthe needle guide legs 53, as depicted in FIGS. 17A-17G, which show theneedle guide 50 as including legs 53 of varying sizes so as to providevarying needle channel-to-probe longitudinal axis angles. This, in turn,causes a needle disposed through the needle channel 54 to intersect theextension of the probe longitudinal axis at differing distances from thesurface of the probe head 18A, according to the needle guide's angle.

In light of the above, FIGS. 17A-17G show needle guides 50 configuredfor approximate intersection distances of 0.5 cm (FIG. 17A), 1.0 cm(FIG. 17B), 1.5 cm (FIG. 17C), 2.5 cm (FIG. 17D), 3.0 cm (FIG. 17E), 3.5cm (FIG. 17F), and 4.0 cm (FIG. 17G).

So configured, multiple needle guides, each having a needle channeldefining a unique angle with the longitudinal axis of the probe, can beconstructed as to be selectively attachable to/removable from the probeneedle guide connector of the probe, enabling a plurality of needleinsertion angles to be achieved with the system 10. Of course, otherangles are also possible. In another embodiment, more than one needlechannel is included on a single needle guide.

FIG. 18 depicts details of the needle guide 50 according to anotherembodiment, including the legs 53 supporting the top surface 52 on whichthe needle channel 54 is disposed. The needle guide 50 includes anextended guide feature for assisting in guiding a needle into the needlechannel 54. The extended guide feature here includes a concavely shapedguide surface 180 defined on the proximal end 50A of the needle guide50. The guide surface 180 is defined by a semicircular perimeter 182such that the guide surface substantially extends the width of the bodyof the needle guide 50 from the perspective shown in FIG. 18. Theperimeter 182 bounds a concavely shaped, conical section surface 184that funnels toward and is in communication with the needle channel 54.

FIGS. 19A and 19B depict details of the needle guide 50 according toanother embodiment, including the legs 53 supporting the top surface 52on which the needle channel 54 is disposed. The needle guide 50 includesan extended guide feature for assisting in guiding a needle into theneedle channel 54. The extended guide feature here includes a guide cone280 having a thickness so as to extend from the proximal end 50A of theneedle guide 50. The guide cone 280 is defined by a circular perimeter282 that bounds a round funnel surface 284 that funnels toward and iscommunication with the needle channel 54. A slot 283 is included in theguide cone 280 to enable removal of the needle therefrom.

FIGS. 20A and 20B depict details of the needle guide 50 according toanother embodiment, including the needle guide body supporting the topsurface 52 on which the needle channel 54 is disposed. The needle guide50 includes an extended guide feature for assisting in guiding a needleinto the needle channel 54. The extended guide feature here includes twoguide wings 380 that extend proximally from the proximal end 50A of theneedle guide 50 in a direction parallel to the top surface 52 such thatan upper surface 382 of the guide wings is substantially parallel to thelongitudinal orientation of the needle channel 54.

The guide wings 380 are positioned proximate the proximal opening to theneedle channel 54 such that a needle that moves atop the upper surface382 of the guide wings can be inserted into the needle channel withminimal effort. FIG. 20B shows that each of the guide wings 380 isshaped in a wing-like fashion so as to converge toward the proximalopening of the needle channel 54, further guiding the user in directingthe needle toward the needle channel. Note that different numbers,sizes, shapes, and configurations of guide wings can be employed withthe needle guide.

FIGS. 21-23 depict additional aspects of the needle guide 50 accordingto example embodiments. In each of the FIGS. 21-23, the needle guide 50defines an extended guide feature including a concavely shaped guidesurface 480 for guiding a needle into the needle channel 54 disposed onthe top surface 52. In FIG. 21 the needle channel 54 is substantiallyliner. In contrast, the needle channel 54 includes a tapered section 490wherein a cross sectional area of the needle channel reduces in sizefrom proximal end to distal end thereof. The tapered section 490 in FIG.22 includes substantially the entirety of the needle channel 54, whilein FIG. 23, the tapered section 490 includes approximately only theproximal half of the needle channel, distal to which the needle channelremains substantially linear. It is contemplated that the tapered natureof the needle channel can vary from what is shown and described herein.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A needle guide for use with a handheld probehaving a connector protruding from a probe surface, comprising: a needleguide body defining: a first surface having a proximal end and a distalend; and a cavity below the first surface, the cavity shaped to receivethe connector; a needle channel defined on the first surface from thedistal end to a proximal section, the needle channel having a fixedsize; a guide cone coupled to the needle channel at the proximal sectionof the first surface, the guide cone having a proximal portion extendingbeyond the proximal end of the first surface of the needle guide body.2. The needle guide as defined in claim 1, wherein the guide coneextends below the first surface of the needle guide body in a directionorthogonal to the first surface.
 3. The needle guide as defined in claim1, wherein the guide cone is circularly funnel-shaped.
 4. The needleguide as defined in claim 1, wherein the guide cone is ellipticallyfunnel-shaped.
 5. The needle guide as defined in claim 4, wherein theelliptical funnel shape of the guide cone is bounded by a perimeter, aleading edge of the perimeter disposed above the first surface of theneedle guide in a direction orthogonal to the first surface, and atrailing edge of the perimeter disposed below the first surface of theneedle guide in a direction orthogonal to the first surface.
 6. Theneedle guide as defined in claim 1, wherein the needle channel isdefined by opposing walls separated by a slot.
 7. The needle guide asdefined in claim 6, wherein at least a portion of the needle channel istapered.
 8. The needle guide as defined in claim 1, wherein the handheldneedle guide body is removably attachable to the handheld probe.
 9. Theneedle guide as defined in claim 8, wherein the handheld probe includesa connector to enable attachment of the needle guide in a snap-fitarrangement.
 10. The needle guide as defined in claim 9, wherein theneedle guide body defines a cavity for receiving the connector therein.11. The needle guide as defined in claim 9, wherein the needle guidebody defines a plurality of notches that respectively receive aplurality of extensions of the connector so as to stabilize attachmentof the needle guide to the connector.
 12. The needle guide as defined inclaim 1, wherein the handheld probe includes an ultrasound probe andwherein the needle guide removably attaches to the ultrasound probe soas to position the needle channel in an angled configuration withrespect to a longitudinal axis of the ultrasound probe.
 13. The needleguide as defined in claim 12, wherein the first surface includes a topsurface of the needle guide body and wherein the needle guide bodyincludes first and second legs, the first and second legs sized tosupport the needle channel of the first surface in the angledconfiguration.
 14. The needle guide as defined in claim 4, wherein theelliptical funnel shape of the guide cone is bounded by a perimeter, aleading edge of the perimeter disposed beyond the proximal end of thefirst surface in a direction parallel to the first surface, a trailingedge of the perimeter disposed distal of the leading edge.
 15. Theneedle guide as defined in claim 1, wherein the needle channel comprisesa lumen defined by a needle channel wall.
 16. The needle guide asdefined in claim 15, wherein the needle channel wall includes a firstside, a second side, and a first slot between the first side and thesecond side.
 17. The needle guide as defined in claim 16, wherein thefirst slot extends an entire length of the needle channel wall from thedistal end to the proximal section of the first surface.
 18. The needleguide as defined in claim 17, wherein the guide cone includes a secondslot in alignment with the first slot.
 19. The needle guide as definedin claim 18, wherein the second slot extends an entire length of theguide cone.
 20. The needle guide as defined in claim 1, furthercomprising a continuous slot through the needle channel and the guidecone, the continuous slot extending from a distal end of the needlechannel through a proximal end of the guide cone.
 21. The needle guideas defined in claim 1, wherein the guide cone includes a slot, andwherein a proximal end of the guide cone includes a continuous perimeterfrom a first side of the slot to a second side of the slot.
 22. Theneedle guide as defined in claim 1, wherein the needle channel comprisesa lumen defined by a needle channel wall and the first surface.